The Food and Drug Administration (FDA) has issued a notice about a new system of records involving information collected from those required to submit user fees to the agency. The notice outlines the types of information collected relating to fees assessed under the Freedom of Information Act, Animal Drug User Fee Act, Animal Generic Drug User Fee Act, and Food Safety Modernization Act, among others. The notice also pertains to fees assessed under the authority of the Federal Food, Drug, and Cosmetic Act, such as “color additive certification fees and export certificate fees.” According to FDA, this information is unclassified and can be used for “routine purposes,” a term that FDA further elaborates in the notice. As FDA notes, “[t]he Privacy Act allows FDA to disclose information without an individual’s consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the…
Category Archives Legislation, Regulations and Standards
The U.S. Senate has approved a bill (S. 743), as amended by the House, that will strengthen whistleblower protections applicable to federal employees. According to the Government Accountability Project’s Food Integrity Campaign, the new legislation, if signed into law as expected by President Barack Obama (D), will protect previously vulnerable employees, such as a Food Safety and Inspection Service (FSIS) district office manager who reports complaints by FSIS poultry inspectors that a company has increased line speeds making it impossible for workers to remove all potentially contaminated fowl from the line. The new law would also protect a Food and Drug Administration (FDA) inspector who exposes falsified Salmonella records at a produce operation and an FDA researcher whose findings on a controversial food ingredient are stifled by management. See Food Integrity Campaign News Release, November 13, 2012; FoodQualityNews.com and Meatingplace.com, November 15, 2012.
Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have reportedly called for a meeting with Food and Drug Administration (FDA) Commissioner Margaret Hamburg after reports surfaced that the agency has received adverse event reports indicating that the caffeinated energy supplement 5-Hour Energy® may have been linked to the deaths of 13 people in the past four years. The product has apparently been mentioned in 90 filings submitted to the agency; the reports include more than 30 that purportedly involved serious injuries such as heart attacks, convulsions and a spontaneous abortion. The senators have questioned the safety of energy drinks in three letters to the agency in recent months; their latest letter states, “[W]e request a meeting with you on the steps FDA is taking regarding highly caffeinated energy drinks and to ensure they are safe for their intended use and in combination with other energy drink ingredients.” The senators also…
San Francisco City Attorney Dennis Herrera has sent a letter to Monster Beverage CEO Rodney Sacks, asking the company to provide proof that the large dosages of caffeine contained in its popular Monster energy drinks are “completely safe” for consumption by adolescents and adults. Monster Beverage Corp. has come under increased scrutiny following reports last week to the Food and Drug Administration (FDA) that the product may be linked to as many as five deaths since 2009. Herrera issued the letter under provisions of California’s Unfair Competition Law that empowers city attorneys to demand evidence for purportedly fact-based advertising claims. “Although you claim that Monster Energy drinks are ‘completely safe,’” Herrera writes, “there is increasing evidence that the high caffeine levels in your products are dangerous, particularly for the youth whom you target with your advertising. As numerous scientific studies have concluded, consuming large amounts of caffeine can have serious health…
U.K. members of Parliament (MPs) have reportedly agreed to revisit a beer duty escalator tax that raises the price of a pint each year by 2 percent plus the rate of inflation. According to media reports, Conservative MP Andrew Griffiths argued in the House of Commons that the current beer tax has cost the country thousands of jobs as beer sales decline and pubs are forced out of business. The debate purportedly concluded with 100 MPs voting to review the tax despite Treasury Minister Sajid Javid’s concern that the government would lose £105 million over the next two years if it were abolished. “The reality is since the introduction of the beer duty escalator [in 2008], beer duty has increased by a crippling 42 per cent,” said Griffiths, who chairs the All-Party Parliamentary Beer Group. “The point about an escalator is you stop when you get to the top. We…
The U.K. Department of Environment, Food and Rural Affairs (DEFRA) has announced a public consultation seeking feedback on proposed legislation that would implement the European Union’s (EU’s) regulation “on the provision of food information to consumers” (Regulation (EU) No. 1169/2011). According to DEFRA, the regulation known as FIC requires food business operators (FBOs) to provide specific information to consumers “so that they are able to make informed choices about the food they buy.” These requirements address a number of technical issues, including (i) “country of origin/place of provenance labeling”; (ii) “mandatory nutrition declaration and voluntary front of pack nutrition labeling”; (iii) “ingredients and nutrition labeling of alcoholic drinks”; (iv) “consumer information about non-prepacked foods”; (v) “food allergen labeling and information”; (vi) “clarity of food labels and minimum font size”; (vii) “labeling of vegetable oil including palm oil”; (viii) “labeling of engineered nano-materials”; and (ix) “quantity labeling.” The U.K. legislation enacting FIC…
The European Food Safety Authority (EFSA) has published a Science Strategy 2012-2016 outlining the agency’s plans to protect the food supply chain “in the coming years through up-to-date, science-based risk assessments.” Intended to complement EFSA’s corporate Strategic Plan 2009-2013, the new strategy reflects internal deliberations among its Scientific Committee, Advisory Forum, Management Board and staff, and various stakeholders. The document focuses on four objectives designed to (i) “further develop [the] excellence of EFSA’s scientific advice”; (ii) “optimize the use of risk assessment capacity in the EU”; (iii) “develop and harmonize methodologies and approaches to assess risks associated with the food chain”; and (iv) “strengthen the scientific basis for risk assessment and risk monitoring.” To achieve these goals, the strategy proposes several key initiatives, including a bid to “enhance the contribution of EFSA staff to support the scientific work of the EFSA Scientific Committee and Scientific Panels.” EFSA has also recommended…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued instructions for inspection program personnel (IPP) to follow “when verifying that large official establishments (with 500 or more employees) that produce meat and poultry products have prepared and are maintaining required written recall procedures.” According to FSIS, the notice complies with a May 8, 2012, final rule outlining requirements for notifying the agency of adulterated or misbranded products and maintaining written recall procedures. It also calls on IPP to remind large establishments “of the availability of food defense plan guidance because food defense plans also facilitate the removal of adulterated products from commerce.” Although food defense plans are currently voluntary, FSIS has stressed that their purpose is to help meat and poultry companies “respond to intentional contamination of products” and may be used with other recall systems. Written recall procedures, however, must “specify how the official establishment…
The Agricultural Marketing Service of the U.S. Department of Agriculture (USDA) has issued a final rule clarifying that the Organic Foods Production Act of 1990 and its implementing regulations require “periodic residue testing of organically produced agricultural products by accredited certifying agents.” Effective January 1, 2013, the rule also “expands the amount of residue testing of organically produced agricultural products by clarifying that sampling and testing are required on a regular basis [and] requires that certifying agents, on an annual basis, sample and conduct residue testing from a minimum of five percent of the operations that they certify.” See Federal Register, November 9, 2012.
Nutritionists and consumer groups have reportedly criticized the U.S. Department of Agriculture (USDA) for reducing its per capita sugar consumption estimate from approximately 100 pounds per year to 76.7 pounds per year. According to an October 26, 2012, New York Times article, Center for Science in the Public Interest (CPSI) Executive Director Michael Jacobson “stumbled across” the agency’s latest assessment “while working on a project on sugar consumption.” Lowering the previous benchmark by 20 percent, the revised numbers apparently raised red flags with Jacobson, who suggested that the methodology used by USDA researchers was “built on a foundation of sand.” “The new estimate is still relying heavily on experts making what seem to me to be largely guesses,” he told Times reporter Stephanie Strom. “Other than the 4 percent they’re getting [from the National Health and Nutrition Examination Survey], what do they really know for certain?” In particular, Strom questioned…
